2024年安全协调员的工作职责_安全协调员岗位职责_安全协调员职责及工作内容
安全协调员工作职责描述范本,安全协调员招聘条件要求会做什么,应聘安全协调员需要做什么工作
安全协调员需要做什么工作
安全协调员工作职责
岗位职责：
1.PreparestherespectivesubmissiondocumentstoHealthAuthorities
2.SupervisionofproperflowofconfirmationsofreceiptofdocumentationsenttotheHealthAuthorities.
3.PreparationandeverydaydistributionofrespectivePatientSafetydocuments.
4.Participationintheverificationprocessofdatacorrectnessintheglobalsafetydatabase.
5.VerificationofcorrectnessandcomplianceofdocumentationsenttoPatientSafetyDepartment
6.PreparationofthePatientSafetytrainingmaterials(incl.confirmations)andlogisticorganizationofthesetrainings
·Editing(whererequiredandasperrequestfromPatientSafetyMember)trainingmaterials
·Preparationofconfirmations,certificates,printingoftrainingmaterialsforparticipants
7.Archivingallsafetydocumentationasperrespectivepolicies,guidanceandprocedures.
8.VerificationandupdateofrespectivePSarchivingsystem(incl.review,update,management)
9.MonitoringofthecompliancewithsupportofPSAssociate
10.Managecollection,processing,documentation,reportingandfollow-upofalladverseeventsreportsforallNovartisgroupproductsfromclinicaltrials,non-interventionalstudies,PatientOrientedPrograms,literature,SpontaneousReports,etc.
11.Recordandtrackreceipts,submissionsanddistributionsofSAEs,SRs,SuspectedUnexpectedSeriousAdverseReaction(SUSAR).
12.Managereporting/submission/distributionofsafetyreports/updates/information(e.g.SAE,SR)toLocalHealthAuthorities(LHA)and/orclinicaloperations.
13.Workwithotherlocal/globalPSassociatestoensureaccurateevaluationofsafetydata.
14.InteractandexchangerelevantsafetyinformationwithLHA,PSassociates,otherfunctionalgroupsandthirdpartycontractor,ifapplicable.
15.SurveyandmonitornationalpharmacovigilanceregulationsandprovideupdatetoglobalPSorganization.
16.Supportindeveloping,updatingandimplementinglocalprocedurestoensurecompliancewithPSglobalproceduresandnationalrequirements.
17.Input,reviewandapprovalofprogramproposalsforlanguage,contentandestablishmentofnecessarycontrolsoncollectionandreportingofadverseeventinformation.
18.Performreconciliationwithotherdepartments(e.g.MedicalInformation,QualityAssuranceandthirdpartycontractor,ifapplicable)forpotentialAEsresultingfrommedicalinquiries,qualityrelatedcomplaintsandothersources.
19.ManagementandmaintenanceofallrelevantPSdatabases.
20.PrepareandsubmitKPIreportsoncomplianceinatimelymannerincludingidentificationofrootcause(s)forlatereportingtoLHA,developmentandimplementationofcorrectiveaction(s)asneeded.
*deletewhennotneeded/notappropriate,ormodifyasperlocalactivities.
任职要求：
·FluentinbothwrittenandspokenEnglish
·Fluentinbothwrittenandspokenlocallanguage
·Experienceonsimilarpositionindrugsafetyordrugregistrationorclinicalresearchdepartmentwouldbeanadditionalasset.
·Provenabilitytoworkincross-functionalteams
·Computerskills(e.g.Excel,Word,PowerPoint)andabilitytolearnnewsystemsquickly.